Co-Chair: Patrick Larcier, Pharm.D., MBA, Senior Director, Head of the Personalized Medicine Group, Voisin Consulting Life Sciences
Co-Chair: Iain D. Miller, Ph.D., EPEMED Board Member, Founder of Healthcare Strategies Group
EPEMED aims to create a central point of communication for all those involved in progressing personalized medicine; determine optimal routes to deliver Personalized Medicine (PM) treatments to patients efficiently and promote a better understanding of the development of personalized medicine through the creation and application of advanced diagnostic tests.
PM has introduced a new mode of thinking with major impacts on all organizations positioned in the field of healthcare. Among these organizations, regulatory agencies are keys stakeholders providing the frame and rules to manage patient-related risks. The regulatory context impact directly on market access conditions for the diagnostic industry in terms of constraints (cost, time) but also for value recognition (e;g. LDT vs approved tests) and innovation for the patients (performance evaluation, availability of new assays). This context is subject to major evolution in the coming years. The EPEMED Regulatory Committee ambition is to impact on the future IVD regulatory landscape for the benefit of patients, industry and translational research.
The regulatory committee of EPEMED will focus on the followings:
For more details, please contact Patrick Larcier at email@example.com